Actively Recruiting
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Led by Biotronik, Inc. · Updated on 2026-04-06
325
Participants Needed
2
Research Sites
106 weeks
Total Duration
On this page
Sponsors
B
Biotronik, Inc.
Lead Sponsor
B
Biotronik SE & Co. KG
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.
CONDITIONS
Official Title
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
- Are 18 years of age or older at the time of consent
- Able to understand the study and provide written informed consent
- Willing and able to complete all study visits and requirements for the full follow-up period
You will not qualify if you...
- AV block with a ventricular escape rhythm of 30 bpm or less at time of consent (restriction removed after early safety phase)
- Femoral venous or cardiac anatomy unsuitable for device implantation
- Morbid obesity preventing device telemetry communication within 20 cm
- Intolerance to dexamethasone acetate
- Presence of other implanted devices that may interfere with the pacemaker or procedure
- Allergy to the pacemaker materials or implant tools
- Previous attempt at leadless pacemaker implantation
- Existing pacemaker, ICD, CRT device, or previous lead extraction with leads left in heart (except temporary pacemakers)
- CIED device extraction within 72 hours or signs of infection post-extraction
- Planned ICD or CRT device implantation
- Unstable angina or recent heart attack within 30 days
- Life expectancy less than 12 months
- Unable to tolerate urgent sternotomy
- Planned right-sided heart intervention within 30 days after implant (except AV nodal ablation after safety phase)
- Listed for or has received heart transplant or has left ventricular assist device
- Participation in other conflicting clinical trials without prior approval
- Unable to attend planned or urgent study visits
- Pregnant or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Kokura Memorial Hospita
Kitakyushu, Fukuoka, Japan, 802-8555
Actively Recruiting
2
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka, Japan, 564-8565
Actively Recruiting
Research Team
J
Jennifer Alkire Project Manager
CONTACT
A
Andreas Peth Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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